is 14239 (1995): orthopaedic drilling instruments - drill ...in is0 7153-1, irefere@ze letter of...
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है”ह”ह
IS 14239 (1995): Orthopaedic Drilling Instruments - DrillBits, Taps and Countersink Cutters [MHD 2: OrthopaedicInstruments, Implants and Accessories]
IS 18239 : 1995 ISO’9714-1 : 1991
Indian Standard
ORTHOPAEDIC DRILLING INSTRUMENTS - DRliL BITS,
TAPS AN-D COUNTERSINK CUTTERS
UDC 616-069.6 : 615.472.3
@ BIS 1995
BUREAU OF INDIAN STANDARDS MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI 110002
February 1995 Price Group 3
)li
Otthopaedic Instruments and AccessoriesSectionafCommittee, MHD 2
NATIONAL FOREWORD
This Indian Standard which is identical with IS0 9714-l : 1991 ‘Orthopaedic drilling instruments - Pan 1 Drilfbiis, taps and countersink cutters’, issued by the International Organization for Stand- ardization (ISO), was adopted by theBureau of Indian Standards on the recommendation of the Orthopaedic Instruments and Access&es Sectional Committee and approval of the Medical Equip- ment and Hospital Planning Division Council.
The text of above mentioned IS0 standardhas been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention is particularly drawn to thefollowing:
a)
9
Wherever the words ‘International Standard’ appear referring to this standard, they should be read as ‘Indian Standard’.
Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use appoint (.) as the decimal marker.
In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which areto be substituted in their place are listed below along with their degree of equivalence for the editions indicated:
International Corresponding Indian Degree of Standard Standard Equivalence
IS0 5835 : 1991 IS 9829 (Part 1) : 1981 Metal bone screws : Technically Pan 1 Screws with asymmetric~thread, variable equivalent fitting (spherical) and IS 9829 (Part 2) : 1981 Metal bone screws : Part 2 Screws with asym- metric thread, conical under surfaces
The concerned technical committee has reviewed the provisions of IS0 7153-l : 1983 referred in this-adopted standard and has decided that this is acceptable for use in conjunction with this standard.
For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2 : 1960 ‘Rules for rounding off numerical values (revised)‘. The number of significant places retained in the rounded off value should be the same as that of the specified value’ in this standard.
Indian Stand&@ .
ORTHOPAEDIC DRILLING INSTRUMENTS - DRILL BITS,
TAPS AND COUNTERSINK; ti#TTERS m.., “”
1 Scope
This part of IS0 9714 specifies materials and me- chanical properties, dimensions and marking re- quirements for drill bits, taps and countersink cutters made of stainless steel for use in orthopaedic surgery with bone screws as specified in IS0 5835.
NOTES
1 The interrelationship of 4nternational Standards deal- ing with bone screws, bone plates and relevant tools is shown for information in annex A.
2 At present only stainless steel has been considered as a material for manufacturing these instruments. Other materials and coatings may be included at a later re- vision.
2 Normative references
The following standards contain provisions which, through reference ini this text, constitute provisions of this part of IS0 91714. At the time of publication, the editions indicated were valid. All standards are subject to revision, aind parties to agreements based on this part of IS0 9714 are encouraged to investt- gate the possibility of applying the most recent edi- tions of the standards indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards.
IS0 5835:1881, implants for surgery - Metal bone screws wJth heq~#@ *dr&e connection, spherical under-surface of head, asymmetrical thread - Di- mensions.
IS0 7153-1:1883, instruments for surgery - Metallic materials - Part 1: Stalhless steel.
3 Materialb and mechanical properties
Drill bits, taps%~I~&~nt~rsink cutters shall be made from metal complyiQg with the requirements given in IS0 7153-1, irefere@ze letter of steel grade: D, H, I and R.
4 Dlmenribn8
4.1 Drill bits
The diameter of the drill bit shall be as -given in table 1. The potmangle shall be in the range 80° to 1000.
4.2 laps
The core diameter and outside diameter shall be as given In table 1. The thread form and pitch shall be that of, the appropriate screw as specffied in IS0 5835.
1
IS 14@% : 1
:7 IS0 9714 1
, I
4.3 Couriters)hk cutters 5 Mark!-
The diameter of the pin and cutter head shall be as given in table 1 ‘and figure 1. The cutter shall be ei- ther of colnical~ form with an angle of BY or of spherical form.
5.1 Drill blts
Drill bits shall be marked with the diameter of the bit, expressed In millimetres.
Figure 1 - Countersink cutter
5.2 laps
Taps shall be marked with the code and nominal size of the screw, as specified in IS0 5835, with which they are Intended to be used.
5.3 Counterslnk cutters
Countersink cutters shall be marked with the nomi- nal sizes of the screw, as specified in IS0 5835, with which they are Intended to be used.
Table I - Dlmenslons of drill bits, taps and countersink cutters Dimensions in mlllimetres
Screws
(These data are extracted from IS0 5835 and are glven here for Informatlon.)
Drill bits Taps’) Countersink cutters
Diameter Mameter
of drill of drill
Intended Intended
Cutter Outslde Core
Pin head
IS0 5835 Nominal Core for drlllfng dlameter dlameter
Pitch dlameter dlameter
code dlameter diameter Pitch for drllllng
clearance ptlot - dt
d2 hole tapping
hots A.02 -0.01 0 -0.15 0 -0.15 0 -0.1 0
-. .-
Screws wlth shallow thread:
HA 1;s 195 1.1 095 1,s 1,l 1.5 191 0.5 1.1 4
HA2 2 1,3 096 2 185 2 193 0,6 1.1 4
HA 2,7 287 199 1 2,7 2 2,7 f,6 1 2,5 6
HA 33 3.5 294 1,25 395 25 385 24 1,25 2.5 6
HA4 4 299 I,5 4 3 4 2,6 185 25 6
HA 4,6 495 3 1,75 4,5 3,2 4,5 3 1,75 4,s 8
HA5 5 395 1,75 5 3,7 5 335 1,75 4,5 8
Screws with deep thread:
HB4 4 1.6 1,75 Not appll- 2 4 1.6 1,75 Not requlred for HS
HB 6,s 6-5 3 2,75 cable to HB screws
3,2 6,s 3 2,75 screws
1) It is recommended that the maxlmum varlatlon from the theoretlcal profile at any point on thread form should not exceed:
- 0,050 mm for HA 1,s and HA 2
- 6,075 mm for HA 2,7 to HA 5
- 0,075 mm for HEt 4 and HB 6,s
Interrelationship
Annex A (informative)
of International Standards dealing and relevant tools
IS 14229 : 1995 IS0 9714 : 1991
with bone screws, bone plates
It has be n decided that the set of International Standards dealing with bone screws, bone plates and relevant tools sh uld be divided into two parallel series. The basis of the division into two series Is the essentially dif- ferent de igns of the screw threads of the bone screws (HA and HEI type screws as opposed to HC and HD type screws).
A simpli ed schematic guide illustrating the interrelationship between screws, plates and tools covered by the parallet f eries of International Standards is given on the following page.
3
IS 14mo:1QQs Is0 9714:1991
Screw8 Heed under-rurface
Thread
Drive connection
HA HB
u s-1
0 \“““/ \‘““/
conical
ec30 Single
slot
1 Combined dr*Ne connectiona
Single slot and cross- recessed
head
Cruciete slot and uo!8s- recessed
head
In preparation
-
Mechanical requirements IS0 6475
Breaking torque/ angle of rotation
Plates IS0 9269
/ =-..1-- Is09585----
Driving toolr
Keys and screwdrivers
IS0 83192 t I
1 Screwdrhfers
IS0 9714-1 -I_ In preparation
4
Cl1
PI
C33
c41
IS 14239’: 199s IS0 9714 : 1991
Annex B (informative)
Biblihgraphy: International Standards referred -to in table in annex A
IS0 5835:1991, implants for surgery - Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread - Dbnensions.
c53
ISO-5836119 8, bone plate with~asym %
implants for surgery - Metal - Holes corresponding to screws
,etrical thread and spherical under-
[61
surface.
c71 IS0 6475:1989, Implants for surgery - Metal bone screws with asymmetrical thread and spherical under-surface - Mechanical require- ments and test methods. VI
IS0 8319-1:1986. Orthopaedic instruments - Drive connections - Part I: Keys for use with screws with hexagon socket heads. C91
IS0 8319-2:1986, Orthopaedic instruments - Drive connections - Part 2: Screwdrivers for sing/e slot head screws, screws with cruciate slot and cross-recessed head screws.
IS0 9268:1988, fmplants for surgery - Metal bone screws with conical under-surface of head - Dimensions.
!SO 9269:1988, implants for surgery - Metal bone plates - Holes and slots corresponding to screws with conical under-surface.
IS0 9585:1990, implants for surgery - Determi- nation of bending strength and stiffness of bone p/&es.
IS0 9714-l:lBBl, Orthopaedic drilling instru- ments - Part 1: Drill bits, taps and countersink cutters.
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